Lead Quality Assurance (QA) Associate

Job Description

When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability, and sustainability standards. http://www.fisherclinicalservices.com/

What will you do?

Position Summary:

Having wide-ranging quality systems experience, uses professional concepts and company objectives to resolve sophisticated issues in creative and effective ways. May participate in processes, projects, or initiatives that are important to the success of the function or team. Networks with key contacts outside own area of expertise. Maintains cGMP compliance under appropriate Quality Systems in Operations.

A Day in the Life:

Proactively identifies and coordinates the reporting of Data Integrity issues and findings through Global TrackWise including reporting observations and ensuring changes are completed as per cGMPs.

Coordinates actions for global harmonization of procedures across Clinical Labeling sites. Responsibilities include implementing and monitoring department gap assessments and completion tracking. Completes Quality gap assessments and documents updates where applicable.

Supports the harmonization of key processes across all Clinical Labeling Services locations. Ensures SOP/WI’s for designated critical processes are applied at other CLS sites and any translated items are associated within Documentum to the primary SOP/WI.

Assist in supporting the management of Documentum (Electronic Document Management Systems, eDMS) for the site with responsibilities for the final release of all quality-controlled Forms, WIs, SOPs, and Manuals ensuring that the documentation is aligned with local and corporate attributes.

Supports internal authors and Subject Matter Experts (SMEs) with the use of Documentum, for document creation, revision, and management.

Monitors all Periodic Reviews from issuance to completion.

Handles the creation and release of site logbooks.

Provides Right First Time, monthly business review site metrics, and department metrics to the QS Manager and site QA Analyst on a routine basis as part of Continuous Improvement efforts.

Participates in, Practical Process Improvement (PPI) teams.

Applies Good Manufacturing Practices principles in all areas of responsibility.

Demonstrates and drives the Thermo Fisher values – Integrity, Intensity, Involvement, and Innovation (The Four Is).

Ensures appropriate execution of Quality Systems (QS) to sustain cGMP compliance.

Coordinates the disposition and destruction of batch records as per corporate guidelines.

Raises issues to Quality Systems Management as needed.

Other duties may be assigned to meet business needs.

Education

Minimum requirements include associate degree.

Equivalent combinations of education, training, and meaningful work experience may be considered.

Experience

A minimum of 5 years of meaningful experience in the pharmaceutical industry or 3 years with an advanced degree.

Knowledge, Skills, Abilities

Knowledge of cGMPs

Outstanding problem-solving skills

Attention to detail

Ability to multi-task

Excellent oral and written communications skills

Ability to work with company/client confidential information

Communicate effectively with all levels of personnel

Work efficiently and accurately in a fast-paced environment

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Compensation and Benefits

The hourly pay range estimated for this position based in New York is $25.00–$35.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.